NDA & EU Regulatory Submissions

Comprehensive experience in NDA and EU regulatory submissions is rare, even among researchers who have successfully advanced development programs to late-stage clinical research. The PROMETRIKA team includes statisticians, medical writers and other clinical research professionals who have successfully developed dossiers for NDA and EU regulatory submissions. Our experience includes highly-specialized statistical analyses of integrated safety data, meta-analyses of efficacy data, and expert medical writing to support the optimal strategies in positioning and presenting clinical research results in submission materials. We often participate in FDA meetings and calls both with and on behalf of our clients.